Mask assembly

ABSTRACT

A mask assembly for delivering breathable gas to a patient may include a patient interface structured to engage the patient&#39;s face and provide a seal, a headgear arrangement to support the patient interface in a desired position on the patient&#39;s face, and an audio unit provided to at least one of the patient interface and the headgear arrangement. The audio unit may be operable to selectively generate at least one sound.

CROSS-REFERENCE TO APPLICATIONS

This application is a divisional of U.S. application Ser. No.13/896,435, filed May 17, 2013, now allowed; which is a divisional ofU.S. application Ser. No. 12/805,828, filed Aug. 20, 2010, now U.S. Pat.No. 8,453,642, which is a divisional of U.S. application Ser. No.11/491,016, filed Jul. 24, 2006, now U.S. Pat. No. 7,798,144, whichclaims the benefit of U.S. Provisional Application No. 60/703,432, filedJul. 29, 2005, each incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to flow generators and mask systems usedin the treatment, e.g., of Sleep Disordered Breathing (SDB) withNon-Invasive Positive Pressure Ventilation (NIPPV).

BACKGROUND OF THE INVENTION

Known flow generators and mask systems are structured solely forgenerating and delivering a supply of pressurized air to be provided toa patient for treatment. The present invention provides improvements toknown flow generators and mask systems to overcome this limitation inorder to enhance and/or facilitate the treatment session.

SUMMARY OF THE INVENTION

One aspect of the invention is directed towards a flow generatorincluding structure to facilitate or enhance sleeping by stimulatinghuman senses such as sight, hearing, touch, and/or smell.

Another aspect of the invention is directed towards a flow generatorand/or mask system that includes visual, audio, and/or aromatic mediumto facilitate or enhance sleeping.

Another aspect of the invention relates to a flow generator forgenerating a supply of pressurized air to be provided to a patient fortreatment. The flow generator includes a housing, a blower provided tothe housing operable to provide a pressurized flow of air at an outlet,and an integral or detachable unit configured to stimulate human sensesto assist in treatment and/or sleep cycle.

Another aspect of the invention relates to a flow generator forgenerating a supply of pressurized air to be provided to a patient fortreatment. The flow generator includes a housing, a blower provided tothe housing, and a projection unit provided to the housing. The bloweris operable to provide a pressurized flow of air at an outlet. Theprojection unit is operable to project an image onto a surface adjacentthe housing. In an embodiment, the projection unit may be controlledbased on at least one monitored parameter of the patient.

Yet another aspect of the invention relates to a flow generator forgenerating a supply of pressurized air to be provided to a patient fortreatment. The flow generator includes a housing, a blower provided tothe housing, and an audio unit provided to the housing. The blower isoperable to provide a pressurized flow of air at an outlet. The audiounit is operable to selectively generate at least one sound. In anembodiment, the audio unit may be controlled based on at least onemonitored parameter of the patient.

Still another aspect of the invention relates to a flow generator forgenerating a supply of pressurized air to be provided to a patient fortreatment. The flow generator includes a housing, a blower provided tothe housing, and an aromatic unit provided to the housing. The blower isoperable to provide a pressurized flow of air at an outlet. The aromaticunit is operable to selectively release at least one therapeutic aroma.In an embodiment, the aromatic unit may be controlled based on at leastone monitored parameter of the patient.

Still another aspect of the invention relates to a mask assembly fordelivering breathable gas to a patient. The mask assembly includes apatient interface structured to engage the patient's face and provide aseal, a headgear arrangement to support the patient interface in adesired position on the patient's face, and an audio and/or aromaticunit provided to at least one of the patient interface and the headgeararrangement. The audio unit operable to selectively generate at leastone sound.

Still another aspect of the invention relates to a device for deliveringdrug or hormonal treatment. The device includes a sleep stage monitorstructured to monitor a patient's sleep stage and a unit structured torelease drug or hormonal treatment to a patient. The unit iscommunicated with the sleep stage monitor such that the release of drugor hormonal treatment is based on the patient's sleep stage.

Still another aspect of the invention relates to a substance deliveryapparatus including a sensor to generate a sleep stage signal indicatinga patient's sleep stage, and a delivery unit structured to releaseand/or deliver a therapeutic or medicinal substance via the patient'sairways in accordance with the sleep stage signal.

Yet another aspect of the invention relates to a method for delivering atherapeutic or medicinal substance. The method includes sensing apatient to generate a sleep stage signal indicating a patient's sleepstage, and releasing and/or delivering a therapeutic or medicinalsubstance via the patient's airways in accordance with the sleep stagesignal.

Yet another aspect of the invention relates to a flow generator forgenerating a supply of pressurized air to be provided to a patient fortreatment. The flow generator includes a control unit to operate theflow generator and an alarm to wake the patient from sleep.

Other aspects, features, and advantages of this invention will becomeapparent from the following detailed description when taken inconjunction with the accompanying drawings, which are a part of thisdisclosure and which illustrate, by way of example, principles of theinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings facilitate an understanding of the variousembodiments of this invention. In such drawings:

FIG. 1 is a perspective view of a flow generator constructed accordingto an embodiment of the present invention, the flow generator includinga projection unit operable to project an image onto a surface;

FIG. 2 is a perspective view of a flow generator constructed accordingto another embodiment of the present invention, the flow generatorincluding a projection unit operable to project an image onto a surface;

FIG. 3 is a perspective view of a flow generator constructed accordingto another embodiment of the present invention, the flow generatorincluding an audio unit operable to selectively generate at least onesound and an aromatic unit operable to selectively release at least onetherapeutic aroma;

FIG. 4 is a schematic view of a controller that controls operation of aflow generator in accordance with an embodiment of the presentinvention;

FIG. 5 is a side view illustrating a mask assembly according to anotherembodiment of the present invention, wherein control features areincorporated into the patient interface and/or headgear arrangement;

FIG. 6 is a side view illustrating a mask assembly including an audiounit according to another embodiment of the present invention, whereinearphones are incorporated into a headgear arrangement;

FIGS. 7A-7B illustrate a mask assembly according to still anotherembodiment of the present invention, wherein an aromatic unit isincorporated into the headgear arrangement;

FIG. 8 is a schematic view of a sleep stage monitor according to anembodiment of the present invention; and

FIG. 9 is a side view illustrating a patient interface integrated witheyeglasses according to yet another embodiment of the present invention.

DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS

FIGS. 1-3 illustrate flow generators 10, 210 constructed according toembodiments of the present invention. The flow generators 10, 210 arestructured to generate a supply of pressurized air to be provided to apatient for treatment, e.g., of Sleep Disordered Breathing (SDB) andNon-Invasive Positive Pressure Ventilation (NIPPY). Moreover, the flowgenerators 10, 210 include visual, audio, and/or aromatic medium toenhance and/or facilitate the treatment session by stimulation of humansenses as discussed in greater detail below.

Flow Generator with Projection Unit

As shown in FIG. 1, the flow generator 10 includes a housing 12 and ablower 14 supported within the housing 12. As is known in the art, theblower 14 is operable to draw a supply of air into the housing 12through one or more intake openings and provide a pressurized flow ofair at an outlet. The supply of pressurized air is delivered to thepatient via an air delivery conduit 16 that includes one end coupled tothe outlet of the flow generator 10 and an opposite end coupled to apatient interface 38 (e.g., see FIGS. 5-7). The patient interface 38comfortably engages the patient's face and provides a seal. The patientinterface 38 may have any suitable configuration as is known in the art,e.g., full-face mask, nasal mask, oro-nasal mask, mouth mask, nasalprongs, etc. Also, any suitable headgear arrangement 40 (e.g., see FIGS.5-7) may be utilized to comfortably support the patient interface 38 ina desired position on the patient's face.

As illustrated, the housing 12 of the flow generator 10 includes anupper wall 18, a lower wall 20, and side walls 22 that interconnect theupper and lower walls 18, 20. A projection unit 24 is supported by orwithin the housing 12. The projection unit 24 is operable to project animage 26 through one of the walls 18, 20, 22 and onto a surface adjacentthe housing 12. Specifically, the projection unit 24 includes a lightsource that casts the image 26 through a lens provided adjacent anopening 28 in one of the walls 18, 20, 22.

As shown in FIG. 1, the housing 12 may be supported on a bedside table30. The opening 28 is provided in one of the side walls 22 of thehousing 12 such that the image 26 is projected onto an upper surface 32of the bedside table 30.

However, the opening 28 may be provided in any one of the walls 18, 20,22 to allow the image 26 to be projected onto any suitable surface. Forexample, FIG. 2 illustrates a flow generator 10 wherein the opening 28is provided in the upper wall 18 of the housing 12 such that the image26 is projected onto a surface 34 of an adjacent wall. However, theprojection unit 24 may be adjustable to allow the patient to select thedesired surface to project the image 26.

The image 26 projected by the projection unit 24 shown in FIGS. 1 and 2may take various forms, and may be configured to enhance and/orfacilitate the treatment session. For example, the image 26 may beconfigured to facilitate and/or sustain sleeping. The image 26 mayinclude a recording, e.g., including audio/visual instructions on how tooperate the flow generator, fit the mask, adjust headgear, etc. Theimage 26 may take the form of a live feed, e.g., where a patient seekslive assistance from a clinician, or where the clinician is remotelymonitoring a parameter of the patient and wants to convey a correctiveaction or other instructions to the patient.

As shown in FIGS. 1 and 2, the image 26 may include a control panel thatillustrates one or more parameters of the flow generator 10, e.g.,treatment pressure, and/or the patient, e.g., heart-rate. Also, theprojected control panel may include known virtual keyboard technologythat enables the patient to adjust the one or more parameters via theprojected control panel. For example, the projected control panel mayinclude projected keyboard and/or arrow keys that can be selected by thepatient or clinician to adjust the magnitude of the treatment pressure.

In another embodiment, the image 26 may include a visual show thatincludes variably changing colors and/or images. For example, theprojection unit 24 may illuminate the adjacent surface in relaxingimages selected to facilitate sleep.

In yet another embodiment, the projection unit 24 may be configured toproject a clock, television programs, movies, and/or internet sites. Theprojection unit 24 may be digital or any other suitable technology.

Flow Generator with Audio and/or Aromatic Unit

FIG. 3 illustrates an embodiment of a flow generator 210 that includesan audio unit 50 and/or an aromatic unit 60 supported by or within thehousing 12. Thus, the flow generator 210 forms a relaxation system thatutilizes audio and/or aromatic medium to facilitate and/or sustainsleeping. It should be understood that the projection unit 24, audiounit 50, and aromatic unit 60 may be provided separately in the flowgenerator 10, 210, or in any combination.

The audio unit 50 is operable to selectively generate, e.g., via aspeaker, at least one sound that passes through one or more openings,e.g., mesh, provided in selected walls of the housing 12. In anembodiment, the sound may be in the form of music, soothing sounds,white noise, and/or noise canceling. The soothing sounds may be, e.g.,sounds of nature, such as the beach, birds, rain, or summer night, thatfacilitate sleep and/or meditation.

In an embodiment, the sound may be emitted down the air delivery conduit16 to be communicated to the patient's head. Also, the sound may also besent wirelessly to an audio unit mounted in the mask, headgear, or thepatient's head.

Also, the flow generator 210 may include a projection unit, likeprojection unit 24 of FIGS. 1-2, that may be coordinated with the audiounit 50. For example, the audio unit 50 may generate the audio thataccompanies the television program and/or movie displayed by theprojection unit. Alternatively, the audio unit 50 may generate ambientsounds that coordinate with the images, e.g., light show, displayed bythe projection unit.

Further, the audio unit 50 may be arranged to play compact discs, tapes,and/or electronic music files, e.g., MP3 files.

The aromatic unit 60 is operable to selectively release one or morearomas, e.g., in the form of aromatherapy, through one or more openingsprovided in walls of the housing 12. In an embodiment, the aromas may beselected to facilitate sleep and/or meditation.

In another embodiment, the aromatic unit may administer inhalationtherapies, inhalation medications, and/or drugs into the air deliveryconduit 16 communicated with the patient interface. The inhalationtherapies, inhalation medications, and/or drugs may include atomized,aerosol, and/or particulate drugs, and may be delivered into the airdelivery path anywhere between the flow generator and the patientinterface. The aromatic unit may be integrated with the flow generatoror may be a separate unit with a bypass tube to add the drug into theair delivery path.

Further, the aromatic and/or medication level may adjust according to alevel of nasal congestion, e.g., higher airway impedance.

Also, the aromatic unit 60 may be coordinated with the projection unitand/or the audio unit 50. For example, the aromatic unit 60 mayselectively release aromas that accompany the image displayed by theprojection unit and/or the audio generated by the audio unit 50. In anembodiment, the aromatic unit 60 may selectively release aromas of thebeach, and the audio unit 50 may generate sounds of the beach.

Control of Projection, Audio, and/or Aromatic Unit

As best shown in FIG. 4, the flow generator 10, 210 of either FIG. 1, 2,or 3 may include a controller 36 operable to receive input signals andto control operation of the blower 14, the projection unit 24, the audiounit 50, and/or the aromatic unit 60 based on the input signals. Theinput signals may be provided by a control unit 37 having a plurality ofcontrol features that can be manually selected and/or adjusted by thepatient. For example, the patient may adjust the blower outlet pressureand/or the desired image to be projected by the projection unit 24.

In an embodiment, the control unit 37 may be provided on the housing 12.In another embodiment, the control unit 37 may be a remote-type controlunit that communicates with the controller 36, e.g., wirelessly. In yetanother embodiment, the control unit 37 may be incorporated into apatient interface 38 and/or headgear arrangement 40 as shown in FIG. 5.

Also, the flow generator 10 may include a patient monitor 42 operable tomonitor at least one patient parameter and generate at least one inputsignal to the controller 36. In an embodiment, the patient monitor 42may be integrated into the patient interface and monitor the respiratoryairflow or effort of the patient which may be associated with thepatient's sleep state. In another embodiment, the patient monitor 42 mayinclude a heart-rate monitor or any other relevant parameter, includingcombinations of parameters. Based on information received from thepatient monitor 42, the controller 36 may selectively control operationof the blower 14, the projection unit 24, the audio unit 50, and/or thearomatic unit 60.

For example, the controller 36 may adjust the image 26 of the projectionunit 24 based on the monitored parameter, e.g., sleep state. In oneembodiment, the projection unit 24 may be controlled (based on thesensed parameter) to display an image 26 as the patient is fallingasleep, and then gradually fade out the image 26 as the patient fallsdeeper into sleep. In another embodiment, the projection unit 24 may becontrolled to adjust the substance of the image 26 based on themonitored parameter. The parameter that is used to control theprojection unit may be a parameter that is already monitored in existingflow generators or mask systems. Moreover, the controller 36 may adjustparameters of the blower 14, e.g., blower outlet pressure, based on themonitored parameter.

Similar to the projection unit 24, the audio unit 50 may be selectivelycontrolled based on information received from a manual control unit 37and/or a patient monitor 42 monitoring one or more patient parameters asshown in FIG. 4. In one embodiment, the controller 36 may adjust thevolume of the audio unit 50 based on the monitored parameter. Forexample, the monitored parameter may be the volume of the patient'sbreathing. Thus, the controller 36 may decrease the volume of the audiounit 50 when the patient's breathing is relatively soft for a sustainedamount of time (e.g., 5-10 minutes), and/or the controller 36 mayincrease the volume of the audio unit 50 (e.g., canceling noise) whenthe patient's breathing is relatively loud for a sustained amount oftime (e.g., 5-10 minutes). In this arrangement, the audio unit 50functions as a noise canceling device to muffle the patient's breathingso it does not wake the patient and/or bed partner during sleep.

In another embodiment, the controller 36 may continuously vary thevolume of the audio unit 50 based on the patient's sleep state. Forexample, the volume may be higher at the beginning of sleep, and thevolume may be gradually decreased as the patient falls deeper in sleep.

As shown in FIG. 4, the aromatic unit 60 may also be selectivelycontrolled based on information received from a manual control unit 37and/or a patient monitor 42 monitoring one or more patient parameters.In one embodiment, the controller 36 may continuously vary the quantityof aroma being released based on the patient's sleep state. For example,the quantity may be higher at the beginning of sleep, and the quantitymay be gradually decreased as the patient falls deeper in sleep.

Also, any one of the projection unit 24, audio unit 50, and aromaticunit 60 may simply be timed with a clock. That is, operation of theprojection unit 24, audio unit 50, and/or aromatic unit 60 may bedetermined by a clock setting, e.g., on/off time, elapsed time, etc.

Patient Interface and/or Headgear with Control Unit

As noted above and illustrated in FIG. 5, a control unit 37 with one ormore control features of the flow generator 10, 210 may be incorporatedinto the patient interface 38 and/or headgear arrangement 40. Thisconfiguration allows the patient to easily adjust one or more parametersof the flow generator 10, 210 without being adjacent to the flowgenerator 10, 210. The control features may be wirelessly communicatedwith the projection unit 24, audio unit 50, and/or aromatic unit 60 toavoid cables that may irritate or become tangled with the patient.

Headgear with Audio Unit

In an alternative embodiment, the entire assembly (including thecontrols and the projection unit 24, audio unit 50, and/or aromatic unit60) may be provided in the patient interface 38 and/or headgeararrangement 40.

FIG. 6 illustrates an embodiment wherein the audio unit 50 may beincorporated into the patient interface or headgear arrangement ratherthan the flow generator 210. As illustrated, straps of the headgeararrangement 40 adjacent the patient's ears may support speakers and/orearphones 52. This arrangement allows the audio, e.g., music, to bedelivered directly to the patient without disturbing the patient's bedpartner. Also, a control unit 37 (buttons, dial-type volume/frequencycontrol, etc.) may be incorporated into the headgear arrangement 40 tocontrol parameters of the audio unit 50. While FIG. 6 shows anarrangement where the audio unit is built into the headgear straps, theaudio unit may be formed as a stand-alone unit that can be retro-fittedonto headgear, e.g., via a clip or Velcro®, etc. The audio unit can beused to transmit sounds that are coordinated with transmissions from aprojection unit.

Headgear with Aromatic Unit

As shown in FIG. 7A, the aromatic unit 60 may be in the form of aromaticstrips 70 that are incorporated into the headgear arrangement 40.Specifically, aromatic strips 70 may be attached, e.g., by stitching, toone or more straps 41 of the headgear arrangement 40 as best shown inFIG. 7B. The aromatic strips 70 may be heat-activated or activated inany other suitable manner. For example, the strips 70 may be passivelyactivated and deactivated by the patient's body heat depending onwhether the headgear is being worn or not. Alternatively, the controllermay activate and deactivate the strips, e.g., via electricalstimulation, based on one or more sensed parameters of the patientand/or blower, or by coordinating with an alarm clock, etc.

Alarm

In an embodiment, an alarm may be incorporated into the flow generator10, 210, patient interface 38, and/or headgear arrangement 40. Forexample, the alarm may be incorporated into the audio unit 50.

Also, a sleep stage monitor may monitor a patient's sleep stage and thenactivate the alarm based on the patient's sleep stage. It is known inthe art that waking a person during a certain sleep stage, e.g., shallowsleep stage, or a particular part of the REM-NREM sleep cycle will makeone feel more alert and energetic.

Thus, the sleep stage monitor may monitor the patient's sleeping patternthroughout the night and activate the alarm to wake-up the patient whenit is the best time to wake-up the patient based on sleep stages, sleepcycles, and the quality of the sleep. The sleep stage monitor and alarmmay be referred to as a sleep clock.

Also, the sleep clock may be used as a training tool until a regularsleeping pattern is established by the patient if the patient has asleeping disorder related to sleeping patterns. However, the sleep clockmay be used by anyone who would like to improve his/her quality ofsleep.

It is noted that the sleep stage monitor may be incorporated into a flowgenerator, patient interface, and/or headgear arrangement.

In another embodiment, a basic alarm clock, i.e., a clock that may beset to provide an audio/visual alarm (e.g., a light, buzzer, or bell) ata desired time, may be incorporated into the flow generator. Noadditional hardware may be required to incorporate the basic alarmclock, e.g., an algorithm may be introduced into the flow generatorsoftware to provide the basic alarm clock features. This allows theexisting control unit (e.g., real time clock, speaker, LCD, and keypad)provided to the flow generator to be used for programming and operatingthe alarm clock. If the flow generator is relatively portable, the basicalarm clock feature may be particularly useful for patient's who travelwith the portable flow generator. In alternative embodiments, a basicalarm clock may be incorporated into the patient interface and/orheadgear arrangement.

Sleep Stage Monitor Coordinated with Drug/Hormone Treatment

In another embodiment, a sleep stage monitor may be coordinated withdrug and/or hormone treatment. That is, the release of drug and/orhormone treatment may be based on the patient's sleep stage as treatmentmay be more optimal at certain sleep stages.

For example, it is known that certain growth hormones are released atcertain parts of the sleep cycles, and that hormones are one of keyfactors that control our well-being, the recovery of the body's agingprocess, and the rest of mind. Thus, coordinating the release of hormonetreatment with the patient's sleep stage via a sleep stage monitor wouldbe more natural. Moreover, the release of hormone treatment may beperformed in a controlled manner, at a regulated pattern, and atparticular parts of the sleep cycle.

The sleep stage monitor may be incorporated into a flow generator,patient interface, and/or headgear arrangement. Also, the drug and/orhormone treatment may be delivered into the air delivery path anywherebetween the flow generator and the patient interface. Moreover, the drugand/or hormone treatment may include atomized, aerosol, and/orparticulate drugs, and the treatment may be provided in a module that isincorporated into a flow generator, patient interface, and/or headgeararrangement.

It is noted that the sleep stage monitor may also be coordinated withthe projection unit 24, the audio unit 50, and/or the aromatic unit 60so that the visual, audio, and/or aromatic medium may be provided basedon the patient's sleep stage.

Embodiment of Sleep Stage Monitor

FIG. 8 is a schematic view that illustrates an embodiment of a sleepstage monitor structured to monitor a person's sleeping pattern andclearly identify the NREM and REM sleep cycles and the durations of eachcycle.

As illustrated, the sleep stage monitor 80 includes sensors 82 thatsense or monitor aspects of a person's body. Monitoring may be done bydetecting eye movement or by receiving signals from electrodes attachedto parts of a person's body. Eye movement may be detected by eye sensorsthat may be worn on the person's forehead like spectacles or headbands.Also, the eye sensors may be incorporated into the patient interfaceand/or headgear arrangement. The electrodes, e.g., body or faceelectrodes, may be in the form of a patch with small suction pads so itattaches to the person's skin.

Signals from the sensors 82 are detected, enhanced, and amplified by thedetector 84 before they are communicated to the central processor 86.The central processor 86 analyzes the signals and determines the part ofthe sleep cycle the person is at, the quality of the sleep, and/or thenumber of sleep cycles completed. Also, the central processor may gatherand analyze information from other inputs 88, such as the blood 02 andthe CO2 levels. As illustrated, the central processor 86 may be aseparate module or may be incorporated into a flow generator 92, forexample.

The clinician can decide which sleep pattern is best suited for eachperson, e.g., based on the patient's age and other physical conditions,and the patient can input how many hours of sleep he/she would like tohave each night based on his/her workload or tiredness during the day.Thus, the outputs 90 are driven according to the sleep pattern selectedby the clinician, the inputs selected by the user, and the quality ofthe sleep monitored from the sensors. The selected sleep pattern may becontrolled by a software program that is based on stored medical data inthe monitor 80 or in a computer. Thus, the information may be updated toenhance the programs.

The central processor 86 may have a large memory to record the sleepingpatterns and other information. The recorded information may be used bya clinician to study the patients sleeping pattern and to enhance thetreatment. Also, the monitor 80 may be connected to a network and bemonitored remotely.

As explained above, the output 90 may be used to trigger an alarm,visual, audio, and/or aromatic medium that stimulates human senses.Also, the output 90 may trigger the release of medication or hormonetreatment. Additionally, the monitor 80 may be programmed to wake-up orreset a person's sleep if he/she is having a very restless sleep due tophysical reasons, bad dreams, and/or REM behavior disorders that ariseduring the night.

The combination of the monitor 80 and a flow generator would not onlytreat sleep apnea but would also enhance the quality sleep.

Additional Embodiments

In another embodiment, as shown in FIG. 9, the patient interface 38,e.g., nasal prongs, may be integrated with the patient's eyeglasses 44.This arrangement may provide more comfort to the patient. Furthermore,the eyeglass material may be constructed from flexible water clearmaterial such as silicone rubber or polyester to prevent contactedpressure sores if the glasses are dislodged relative to the patient'sface.

In still another embodiment, the flow generator may include a cameraand/or infrared lighting to allow further monitoring of a patient'scondition. The camera and/or infrared lighting may include one or morefeatures, e.g., a shutter, to allow the patient to maintain privacy asdesired.

While the invention has been described in connection with what arepresently considered to be the most practical and preferred embodiments,it is to be understood that the invention is not to be limited to thedisclosed embodiments, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the invention. Also, the various embodiments described abovemay be implemented in conjunction with other embodiments, e.g., aspectsof one embodiment may be combined with aspects of another embodiment torealize yet other embodiments. In addition, while the invention hasparticular application to patients who suffer from OSA, it is to beappreciated that patients who suffer from other illnesses (e.g.,congestive heart failure, diabetes, morbid obesity, stroke, barriatricsurgery, etc.) can derive benefit from the above teachings. Moreover,the above teachings have applicability with patients and non-patientsalike in non-medical applications.

1-20. (canceled)
 21. A mask assembly for delivering breathable gas to apatient, comprising: a patient interface structured to engage thepatient's face and provide a seal; a headgear arrangement to support thepatient interface in a desired position on the patient's face; and anaudio unit provided to at least one of the patient interface and theheadgear arrangement, the audio unit operable to selectively generate atleast one sound.
 22. The mask assembly according to claim 21, whereinthe audio unit is controlled based on at least one monitored parameterof the patient.
 23. The mask assembly according to claim 21, wherein theaudio unit is incorporated into the headgear arrangement adjacent theears of the patient.
 24. The mask assembly according to claim 21,further comprising a control unit provided to at least one of thepatient interface and the headgear arrangement, the control unitoperable to control operation of the audio unit.
 25. The mask assemblyaccording to claim 24, wherein the control unit is further operable toadjust one or more parameters of a flow generator configured to deliverthe breathable gas to the mask assembly.
 26. The mask assembly accordingto claim 21, further comprising an aromatic unit provided to at leastone of the patient interface and the headgear arrangement, the aromaticunit operable to selectively release at least one aroma.
 27. The maskassembly according to claim 26, wherein the aromatic unit is controlledbased on at least one monitored parameter of the patient.
 28. The maskassembly according to claim 26, further comprising a control unitprovided to at least one of the patient interface and the headgeararrangement, the control unit operable to control operation of thearomatic unit.
 29. The mask assembly according to claim 28, wherein thecontrol unit is further operable to adjust one or more parameters of aflow generator configured to deliver the breathable gas to the maskassembly.
 30. The mask assembly according to claim 21, furthercomprising a projection unit provided to at least one of the patientinterface and the headgear arrangement, the projection unit operable toproject an image onto a surface adjacent the mask assembly.
 31. The maskassembly according to claim 30, wherein the projection unit iscontrolled based on at least one monitored parameter of the patient. 32.The mask assembly according to claim 30, further comprising a controlunit provided to at least one of the patient interface and the headgeararrangement, the control unit operable to control operation of theprojection unit.
 33. The mask assembly according to claim 32, whereinthe control unit is further operable to adjust one or more parameters ofa flow generator configured to deliver the breathable gas to the maskassembly.